Kornimate/medical-research-clean huggingface dataset:
comparison of discover™ artificial cervical disc and acdf for treatment of cervical ddd (ide study)

Conditions: Cervical Degenerative Disc Disease

Summary: this study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. the patients will be randomized to the discover artificial cervical disc (total disc replacement) or slim-loc™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. follow-up on patients treated with total disc replacement will be continued to 5 years post operative.

this study is designed as a multicenter, prospective, randomized, controlled trial. subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. participants in the treatment group will undergo cervical total disc replacement with the discover artificial cervical disc. participants in the control group will undergo anterior cervical discectomy and fusion with the slim-loc™ anterior cervical plate system with a cortical or cortico-cancellous allograft spacer. follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the discover treatment will complete their participation at 5 years post operative. follow-up for the discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.

Eligibility criteria:
key inclusion criteria: * objective evidence of cervical disc disease in 1 vertebral level between c3-c7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement * unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management * moderate neck disability index (ndi) score * able to give informed consent for study participation * able and willing to return for all follow-up visits key exclusion criteria: * significant cervical degenerative disc disease * prior fusion procedure at any level(s) (c1-t1) * marked cervical instability on lateral or flexion/extension radiographs * presence of systemic infection or infection at the surgical site * diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing * history of alcohol and/or drug abuse * any known allergy to a metal alloy or polyethylene * morbid obesity * any significant general illness (e.g., metastatic cancer, hiv)

Keywords: cervical spinal arthroplasty disc surgical acdf ddd
role of senescent cells in uterine fibroid pathogenesis (soul study)

Conditions: Fibroid; Leiomyoma

Summary: the investigators are evaluating the role of senescent cells in uterine fibroids.

uterine fibroids are prevalent tumors of uterus characterized by excessive fibrotic tissues. using new cutting-edge computational methods, the investigators have found that small groups of senescent cells in fibroids work in concert with immune cells to produce soluble factors in fibroid tissues to create a feed-forward loop leading to fibrosis. this project seeks to unravel key cell-cell communication networks involving senescent and immune cells in fibroids to develop new treatments for uterine fibroids.

Eligibility criteria:
inclusion criteria: * subjects must be women above the age of ≥18 - ≤55 years. * women with suspected uterine fibroids. * subject must be or have been sexually active or have had a previous vaginal exam that used a speculum. * subject must be able to understand, read and speak english or spanish and subsequently, be able to understand what she is consenting to in terms of procedures and use/disclosure of protected health information. exclusion criteria: * unwilling to sign the consent form or complete questionnaire. * pregnancy. * cancer of the uterus

Keywords: senescent cells fibroids leiomyomas
survey on belgian patients suffering from irregular heartbeat and starting treatment with a drug to prevent blood clots in blood vessels and the heart. this study is also called belancos.

Conditions: Atrial Fibrillation

Summary: in this study researchers want to learn more about the patient's and treating doctor's concerns about possible bleedings during treatment with drugs preventing blood clots in blood vessels and the heart - so called blood thinner. the study also wants to find out more about the patient's knowledge on the importance, risks and benefits of treatment with this drug group. patients with irregular heartbeat not caused by valvular heart disease who will start treatment with a blood thinner will be asked by their treating cardiologist to complete a questionnaire related to their knowledge and fear of possible bleedings or stroke (blockage or rupture of a blood vessel to the brain) due to the intake of a blood thinner. the treating doctor will complete a similar questionnaire. the study plans to involve 15 cardiologists and 300 patients in belgium.


Eligibility criteria:
inclusion criteria: * male or female adult patients diagnosed with nvaf. * noac treatment-naive patients who will start a noac treatment. exclusion criteria: * previous stroke or thrombosis * previous severe bleeding
near-infrared fluorescent sentinel lymph node mapping for breast cancer

Conditions: Breast Cancer

Summary: sentinel lymph node (sln) mapping is the standard of care for the surgical staging of breast cancer. we propose a method of sln mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. the present study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging system.

the standard of care in breast cancer surgery includes identification and assessment of the sentinel lymph node (sln). at the present time, sln mapping utilizes a gamma ray-emitting radiotracer and/or a blue dye. radiotracers provide sensitive detection of slns, but require involvement of a nuclear medicine physician, vary widely in transit time depending on the agent employed, can be difficult to localize with a handheld gamma probe, and expose both patient and caregivers to ionizing radiation. blue dyes, such as isosulfan blue, cannot be seen easily through skin and fat, but can aid in definitive identification of the sln when the handheld gamma probe gives ambiguous results. finally, the learning curve associated with expertise in the sln procedure is quite long using currently available techniques. in this 12-patient pilot study, we are testing a new intraoperative imaging system that we developed for image-guided surgery. the imaging system uses invisible, near-infrared (nir) light to visualize lymphatic flow and to identify the sln. the imaging system makes no contact with the patient and can display surgical anatomy simultaneously with nir fluorescence. all patients will receive the standard of care for sln mapping, namely technetium-99m sulfur colloid lymphoscintigraphy. in addition, patients will be injected with indocyanine green (icg) diluted in human serum albumin (hsa). icg is already fda approved for other indications and is used in this study at 400-fold to 2000-fold lower than the typical clinical dose. dilution into hsa improves the brightness of icg by over 3-fold, making it an excellent tracer for lymphatic flow. the purpose of this pilot study is to determine whether the ergonomics of the imaging system interfere with typical clinical workflow during breast cancer surgery. a secondary goal is to optimize the imaging parameters (light levels, exposure time, etc.) associated with identification of the sln.

Eligibility criteria:
inclusion criteria: * women or men above the age of 21 who have biopsy-proven breast cancer, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease. exclusion criteria: * pregnant women, * significant renal, cardiac, or pulmonary disease, * history of iodine allergy.

Keywords: sentinel lymph node mapping breast cancer near infrared imaging
validation of salivary proteomic biomarkers for early detection of oral cancer in egyptian population

Conditions: Oral Cancer

Summary: the present investigation was conducted on 100 individuals allocated into four groups; 25 healthy controls, 25 patients having opmds with dysplasia; 25 patients having opmds without dysplasia, and 25 oral cancer patients. demographic data including data related to different risk factors, modified gingival index, oral hygiene level, in addition to salivary levels of il-6, il-8 and scd44 were assessed.

histopathologic evaluation: biopsy samples were obtained from all lesions to verify the diagnosis and establish the presence of dysplasia in the potentially premalignant lesions before allocating patients to their specific groups. history and clinical assessment: demographic data as age and gender, medical history and habits as smoking and alcohol were obtained during patient interview. modified gingival index (mgi), level of oral hygiene (oh) and the number of remaining natural teeth were also assessed. subjects not willing to sign a written informed consent, pregnant females, lactating mothers, and patients with immunosuppressive disorders were excluded. modified gingival index (mgi) evaluates the presence and degree of gingival inflammation. a score of 0 means absence of inflammation. 1 indicates mild inflammation (slight redness) of any part of the gingiva. 2- mild inflammation of the whole gingiva. 3- moderate inflammation (moderate redness, edema, and/or hypertrophy) of the gingiva. 4-severe inflammation (marked redness and spontaneous bleeding) of the gingiva. level of oh care was evaluated corresponding to the oh habits of the patient and efficiency of plaque removal. oh, level is scored as: 1- very good, 2- good, 3- fair, and 4- poor oh. collection of 1.0-2.0 ml of whole unstimulated saliva was obtained between nine and twelve in the morning, to evade diurnal alteration. participants refrained from eating, smoking, brushing, and mouthwash use, 2 hours before to salivary sampling, which were stored at -70 ◦c till analyzed. quantification of salivary il-6, il-8, and scd44 in all samples using an elisa kit list of abbreviations: oscc: oral squamous cell carcinoma opmds: oral potentially malignant disorders hnscc: head and neck squamous cell carcinoma mgi: modified gingival index. oh: level of oral hygiene roc: receiver operating characteristic

Eligibility criteria:
inclusion criteria: * patients above 18 years both males and females patients presenting with opmds
injection intervals in real-world neovascular age-related macular degeneration (namd) patients switching to brolucizumab with at least 12 months of follow-up

Conditions: Neovascular Age-related Macular Degeneration

Summary: this retrospective study included namd patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (bro) cohorts, which consisted of namd patient eyes who switched from a previous anti-vascular endothelial growth factor (vegf) and had ≥3 brolucizumab injections with no other anti-vegf in the first 12 months (360 days) and 18 months (540 days) of follow-up respectively; and the 12-month and 18-month alternating (alt) cohorts, which consisted of namd patient eyes who switched from a previous anti-vegf to brolucizumab and had ≥2 brolucizumab injections and ≥1 injection of another anti-vegf in the first 12 months and 18 months of follow-up, respectively.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of namd. * patients were on a previous anti-vegf therapy and then switched to brolucizumab. * patients remained on brolucizumab for at least 12 months. * patients had exactly 360 days or more of follow-up after first brolucizumab injection. * for bro cohort only: patients received at least three injections of brolucizumab during study period. * for alt cohort only: patients received at least two injections of brolucizumab and one injection of another anti-vegf during the study period. exclusion criteria: * for bro cohort only: patients who received any other anti-vegf therapy during the 12-month follow-up period. * eyes missing bilaterality information in their namd diagnosis. * eyes missing bilaterality information in their brolucizumab injections.

Keywords: namd
cognitive screening in lung cancer patients

Conditions: Lung Disease; NSCLC (Non-small Cell Lung Cancer); SCLC

Summary: this study aims to investigate the occurrence of cancer and adjuvant therapy-related cognitive impairment in patients with both nsclc and sclc. the primary endpoint measure will be the presence of cognitive impairment during the first year after enrollment through the administration of a comprehensive neuropsychological assessment.


Eligibility criteria:
inclusion criteria: * small-cell and non-small-cell lung cancer (stage i, ii, iii, iv) * age ≥ 18 years * patients able to speak and read the local language(s) fluently * acceptance and signature of informed consent exclusion criteria: * age ≥ 70 * presence of brain metastases * patients with concomitant neurological or psychiatric disorders. * patients undergoing brain radiotherapy * previous diagnosis of lung cancer

Keywords: lung cancer nsclc sclc cognitive
muscular strengthening for paretic knee flexor and extensor by conventional physiotherapy on chronic hemiplegic stroke patients

Conditions: Hemiplegia; Stroke

Summary: gait impairment remain one of the main problem for hemiplegic stroke patients. after the 6 first months, stroke patients are classically described with moderate or no improvement. here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular strengthening program with conventional physiotherapy delivered by the local physiotherapist of the patient, in a very ecological way.

gait impairment remain one of the main problem for most of chronic hemiplegic stroke patients. after the 6 first months, stroke patients are classically described with moderate or no improvement for motor skills. however, physiothertapy is very often delivered to try to increase motor performance. here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular strengthening program with conventional physiotherapy delivered by the local physiotherapist of the patient, in a very ecological way. patients will be randomly affected to one group with the same amount of physiotherapy (at least 3 times weekly for 6 weeks). assessment will be done blindly by another physiotherapist, before, after the 6-week treatment and 6 weeks later to evaluate immediate and remaining benefits of each treatment.

Eligibility criteria:
inclusion criteria: * hemipegia due to ischaemic or hemorrhagic stroke more than 6 months ago * 1st and unique cerebral lesion (xscan or mri) * ability to walk 15 m with or without cane or crutch * able to understand and give approved consent * quadriceps at 3/5 (mrc) or stronger exclusion criteria: * current treatment with botulinum toxin for spasticity of the paretic flexor or extensor of the knee * cardiovascular disease contra-indicating effort and strengthening * pregnancy * evolving pathology * rheumatic disease of the knee contraindicating strengthening * aphasia with severe comprehension impairment

Keywords: stroke hemiplegia gait strengthening physiotherapy
safety/efficacy of balicatib (aae581) in adults with osteoarthritis of the knee

Conditions: Knee Osteoarthritis

Summary: this study will test efficacy and safety of aae581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by x-ray


Eligibility criteria:
inclusion criteria: * at least one knee with osteoarthritis with kellgren-lawrence grade 3 * significant osteoarthritis pain in the knee * presence of at least one of the risk factors: obesity (bmi \> 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement exclusion criteria: * women with childbearing potential * secondary osteoarthritis * treatment with intra-articular or systemic steroids * inability to undergo mri acquisition other protocol defined inclusion/exclusion criteria may apply.

Keywords: knee, osteoarthritis, pain, disease modifying
zoomit-fmri identifies motor functional cortex

Conditions: Gliomas

Summary: this study was designed to collect a series of patients with gliomas which were involved in motor cortex to analyze difference accuracy of motor cortex localization between bold-fmri and zoomit-fmri.

gliomas will lead motor dysfunction when they are involved in motor cortex. however, tumor resection also have risk to lead postoperatively motor function deficits if destroy patients' motor cortex when tumor removed. hence, it is important for neurosurgeon to realize the situation of patients' motor cortex locations in order to determine personal operative protocol. the blood oxygen level dependent fmri (bold-fmri) is a prevalent preoperative method to localization motor cortex. it shows motor relevant cortex by the change of blood oxygen level when patients cooperate to finish motor tasks. the advantage of bold-fmri includes higher time and spatial resolution, higher sensitivity, non-invasive. however, its accuracy of localization has not been satisfactory because neurovascular uncoupling. the zoomit-fmri is a novel technic which is evolved from conventional bold-fmri to localize motor functional cortex.the advantage of zoomit-fmri is smaller field of view (fov) and higher spatial resolution comparing with bold-fmri. that helps to reduce other region of brain interference and elevate accuracy of localizations. in this study, the investigators plan to enroll 60 patients, whose gliomas are involved in motor cortex, to acquire their bold-fmri and zoomit-fmri data in order to analyze their difference in the accuracy of motor cortex localization.

Eligibility criteria:
the inclusion criteria were as follows: 1) age ≥ 18 years; 2) no history of surgical treatment or radiotherapy; 3) no contraindication to mri scanning; 4) agreeable to receive the fmri scanning and awake craniotomy with dcs. the exclusion criteria were as follows: 1) basing on the anatomic mri, the distance from the tumor to the hand-knob area lower than 20 mm; 2) disable to finish the task of clenching fist during fmri scanning.

Keywords: gliomas motor functional cortex zoomit-fmri bold-fmri
survey on cardiovascular events in patients with metabolic disease on chronic carnitine supplementation

Conditions: Metabolic Disorders

Summary: the purpose of this study is to learn about the effects of long term carnitine use in patients with metabolic disorders and its potential relationship to cardiovascular events.

this online cross-sectional survey will examine the self-reported long-term carnitine use in patients with metabolic disorders and any potential relationship to cardiovascular events.

Eligibility criteria:
inclusion criteria: * diagnosis of mitochondrial disease or any other metabolic disorder * any age group * namdc or rdcrn registry participant exclusion criteria: * inability to provide informed consent and complete survey * lack of participation in namdc or rdcrn registry
effects of yoga on menopausal symptoms in women with breast cancer

Conditions: Menopause; Breast Cancer

Summary: women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. yoga has been shown to reduce menopausal symptoms as well as symptoms associated with breast cancer. therefore, this study aims to investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with breast cancer and breast cancer survivors.


Eligibility criteria:
inclusion criteria: * breast cancer (stage i-iii) * after completion of surgical therapy * after completion of adjuvant radiotherapy and chemotherapy * score of 5 or greater on the menopausal rating scale * physical and cognitive capacity to participate in the yoga intervention * willingness to participate in 10 or more of the 12 yoga interventions * signed informed consent exclusion criteria: * regular yoga practice in the past 12 months * planned surgery in the study period * diagnosed and medically treated psychosis * hormone replacement therapy
randomized phase iii study of ts-1 alone versus ts-1 plus cddp in advanced gastric cancer

Conditions: Gastric Cancer

Summary: this study aimed to verify the survival benefit of ts-1 plus cddp combination chemotherapy compared with the monotherapy by ts-1 alone.

this is a randomized, controlled, open-label, parallel, multicenter study. patients are stratified according to 3 factors ; performance status (ecog scale: 0, 1, 2), disease stage (unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant chemotherapy or not)) and participating center. patients are randomized to one of two treatment arms. arm a: patients receive oral ts-1 twice daily on days 1-28 followed by 14 days rest. treatment is repeated every 42 days for up to 4 courses. arm b: patients receive cddp iv on day 8 and oral ts-1 twice daily on days 1-21 followed by 14 days rest. treatment is repeated every 35 days for up to 5 courses. patients are followed every 6 months for up to 2 years from the day they participates in this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma * unresectable and recurrent gastric cancer * age 20 to 74 * performance status 0, 1, or 2 (ecog) * life expectancy 3 months * no prior chemotherapy or radiotherapy for gastric cancer * able to take oral medication * evaluable or not evaluable lesion had already checked more than 28 days before participated in this study * hematopoietic absolute granulocyte count lower limit of normal-12,000/mm\^3 platelet ≥ 100,000/mm\^3 hemoglobin ≥ 8.0 g/dl * hepatic ast and alt ≤ 100 u/l alp ≤ 2 times upper limit of normal (uln) bilirubin ≤ 1.5 mg/dl * renal plasma creatinine ≤ uln creatinine clearance ≥ 50 ml/min exclusion criteria: * pregnant or nursing * bleeding from gastrointestinal tract or no diarrhea * hypersensitivity to ts-1 or cddp * psychiatric disorder that would preclude study compliance or giving informed consent * severe acute or chronic medical or psychiatric condition or laboratory abnormality * serious illness or medical condition * brain metastasis * ascites requiring drainage

Keywords: stomach cancer
cerebral oxygenation and awareness during vt ablation

Conditions: Cerebral Oxygenation

Summary: it is aimed to examine the effect of the decrease in blood pressure that occurs during the ventricular tachycardia ablation process on cerebral oxygenation and awareness. patient's age, cardiac measurements (ejection fraction-ef), basal vital values, procedure time (especially activation and pacing mapping), and localization of the arrhythmia, may affect the nirs and bis response to blood pressure drop. in addition to the effects of patients' demographic information, cardiac capacity and procedure time on nirs and bis values (downtrend and duration), correlations of these values with other monitoring parameters (etco2 and spo2) intended to be displayed.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 * patients who will undergo vt ablation * patients who want to participate in the study exclusion criteria: * patients whose baseline values could not be obtained before induction * patients with severe neurological or psychiatric illness * patients who do not want to participate in the study

Keywords: cerebral oxygenation ventricular tachycardia ablation